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| ID | Type | Description | Link |
|---|---|---|---|
| D5395C00039 |
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The purpose of this study is to compare tamoxifen, versus a newer treatment, ARIMIDEX, which we already know to be well tolerated. The main objectives of this research study are to see whether using these drugs will shrink down tumours before surgery and to see if any shrinkage in the tumour affects the extent of surgery that is required.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARIMIDEX (anastrazole) | Drug | |||
| NOLVADEX (tamoxifen) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Objective tumour response | Assessed at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological response | Assessed at 3 months | |
| Extent of breast surgery | Assessed at 3 months | |
| Extent of axillary down-staging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Arimidex Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Santa Rosa | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16598749 | Result | Cataliotti L, Buzdar AU, Noguchi S, Bines J, Takatsuka Y, Petrakova K, Dube P, de Oliveira CT. Comparison of anastrozole versus tamoxifen as preoperative therapy in postmenopausal women with hormone receptor-positive breast cancer: the Pre-Operative "Arimidex" Compared to Tamoxifen (PROACT) trial. Cancer. 2006 May 15;106(10):2095-103. doi: 10.1002/cncr.21872. | |
| 22136317 |
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| Assessed at 3 months |
| Clinical ultrasound response versus clinical caliper response | Assessed at 3 months |
| Safety | Assessed up to 5 years + 30 days |
| Complications due to surgery | Assessed up to 30 days post-surgery |
| Health economics outcomes | Assessed up to 30 days post-surgery |
| Quality of Life assessments | Assessed at 3 months |
| Effect of ethnicity with respect to baseline patient and tumour characteristics, safety and objective tumour response rate | Assessed up to 5 years + 30 days |
| Recurrence-free survival and survival | Assessed up to 5 years |
| New Britain |
| Connecticut |
| United States |
| Research Site | Torrington | Connecticut | United States |
| Research Site | Springfield | Illinois | United States |
| Research Site | Mason City | Iowa | United States |
| Research Site | Baton Rouge | Louisiana | United States |
| Research Site | Pittsfield | Massachusetts | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Albuquerque | New Mexico | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Olympia | Washington | United States |
| Research Site | Antwerp | Belgium |
| Research Site | Hasselt | Belgium |
| Research Site | Leuven | Belgium |
| Research Site | Liège | Belgium |
| Research Site | Rio de Janeiro | Rio de Janeiro | Brazil |
| Research Site | Porto Alegre | Rio Grande do Sul | Brazil |
| Research Site | São Paulo | São Paulo | Brazil |
| Research Site | Fortaleza | Brazil |
| Research Site | Porto Alegre | Brazil |
| Research Site | Sheffield | Brazil |
| Research Site | Edmonton | Alberta | Canada |
| Research Site | Newmarket | Ontario | Canada |
| Research Site | Chicoutimi | Quebec | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Québec | Quebec | Canada |
| Research Site | Brno | Czechia |
| Research Site | Nová Ves pod Pleší | Czechia |
| Research Site | Olomouc | Czechia |
| Research Site | Peské Budjovice | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Praha-5 | Czechia |
| Research Site | Lyon | Cedex 08 | France |
| Research Site | Avignon | France |
| Research Site | Dijon | France |
| Research Site | Limoges | France |
| Research Site | Lyon | France |
| Research Site | Marseille | France |
| Research Site | Montpellier | France |
| Research Site | Nice | France |
| Research Site | Paris | France |
| Research Site | Tours | France |
| Research Site | Budapest | Hungary |
| Research Site | Győr | Hungary |
| Research Site | Kecskemét | Hungary |
| Research Site | Szeged | Hungary |
| Research Site | Szolnok | Hungary |
| Research Site | Bologna | BO | Italy |
| Research Site | Cagliari | CA | Italy |
| Research Site | Monserrato | CA | Italy |
| Research Site | Kashiwa | Chiba | Italy |
| Research Site | Florence | FI | Italy |
| Research Site | Genova | GE | Italy |
| Research Site | Palermo | PA | Italy |
| Research Site | Reggio Emilia | RE | Italy |
| Research Site | Nagoya | Aichi-ken | Japan |
| Research Site | Chiba | Chiba | Japan |
| Research Site | Matsuyama | Ehime | Japan |
| Research Site | Fukuoka | Fukuoka | Japan |
| Research Site | Kitakyushu | Fukuoka | Japan |
| Research Site | Ōta | Gunma | Japan |
| Research Site | Fukuyama | Hiroshima | Japan |
| Research Site | Sapporo | Hokkaido | Japan |
| Research Site | Amagasaki | Hyōgo | Japan |
| Research Site | Isehara | Kanagawa | Japan |
| Research Site | Yokohama | Kanagawa | Japan |
| Research Site | Kumamoto | Kumamoto | Japan |
| Research Site | Niigata | Niigata | Japan |
| Research Site | Ōita | Oita Prefecture | Japan |
| Research Site | Osaka | Osaka | Japan |
| Research Site | Sayama | Osaka | Japan |
| Research Site | Suita | Osaka | Japan |
| Research Site | Kitaadachi | Saitama | Japan |
| Research Site | Chūō | Tokyo | Japan |
| Research Site | Nijmegen | Netherlands |
| Research Site | Sittard | Netherlands |
| Research Site | The Hague | Netherlands |
| Fujiwara Y, Takatsuka Y, Imoto S, Inaji H, Ikeda T, Akiyama F, Tamura M, Miyoshi K, Iwata H, Mitsuyama S, Noguchi S. Outcomes of Japanese breast cancer patients treated with pre-operative and post-operative anastrozole or tamoxifen. Cancer Sci. 2012 Mar;103(3):491-6. doi: 10.1111/j.1349-7006.2011.02171.x. Epub 2012 Jan 13. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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